In just the past five years, significant changes have occurred in how new drugs come to market. Demands for real world evidence and patient-reported outcomes are changing how and when new drugs file for approval. Accountable care organizations (ACOs), integrated delivery networks (IDNs), advocacy groups, and payers are increasingly flexing their muscles. Yesteryear's tried-and-true paths to commercialization have developed new twists and turns, and the ecosystem has become more complicated. Here are just a few of the most important ways our world has changed:
Emerging pharma and biotech increasingly are succeeding on their own
In the past, startups with a strong asset would search for large partners or out-licensing deals. Today, however, many are looking instead for solutions that let them go it alone. Thanks to a stronger economy, there's more capital available to them for activities beyond R&D, including funds for brand development, market conditioning, and engagements with opinion leaders. More than ever, they are prepared to invest not only in preclinical/clinical development, but also in other areas vital to launch—including key opinion leader management, negotiations with payers and stakeholders, promotion to clinicians, and even direct-to-consumer advertising in some cases.
There's also an increasing consensus that emerging enterprises don't always need a big, well-established pharma partner to connect effectively with stakeholder audiences. In orphan drugs and treatment-resistant cancers, for example, patient populations are often small, treatment is delivered primarily at centers of excellence, and relatively few clinicians and payers control what gets prescribed. That makes commercialization less of a large-scale enterprise.
Another factor: The large sales forces big pharma once offered have shrunk; their influence has dwindled, as well. While they still command priority access to stakeholders and bring scale to production and marketing, major players today have less to offer as a partner, particularly if an asset has a compelling value proposition and strong intellectual property protection.
Equally important, independence puts the inventors and investors in greater control of sales and marketing priorities than they would as minor partners to pharma behemoths.
Brain drain in Big Pharma means gain for mid-size and biotech
The intellectual capital available to smaller pharma has grown as well. Companies focused on oncology and orphan drug products increasingly attract top performers from conventional pharma—highly experienced executives whose entrepreneurial bent may have been stifled within corporate walls. They've seen smaller companies gain a head start over larger competitors by being more nimble and having fewer layers of management. Paths to leadership positions may have fewer obstacles when companies are leaner. These executives bring vital knowledge about sales and marketing strategy, as well as market access. Successful emergent manufacturers tend to balance these seasoned professionals from Big Pharma with others who bring savvy gained via multiple startups. Together, they make a winning combination.
Early birds are flying ahead of competitors
The biggest mistake we see today's commercialization teams making is getting too late a start. Conventional wisdom once called for 12 to 18 months of market prep before launch. Today, that doesn't allow enough time to strategize access via IDNs and ACOs, nor to weigh and balance the myriad channels of communication that now proliferate. A new corporate entity unknown to its audience must establish evidence not only for its asset's efficacy and safety, but also for its ability to take an innovation from bench to bedside.
Starting conversations earlier allows you to gain greater insight about the marketplace, the competitive landscape, and where your asset best fits, so that when you launch you're in a position to be more informative to your buyers. A minimum of 24 months has become the new baseline; 36 months is even better. Many companies don't factor in the financing or planning time to do that. The ones that do, however, develop the strongest relationships with opinion leaders, payers, advocacy, and prescribers—and reap the profits.
Sales has morphed into education
Today's payer landscape increasingly defines the role sales reps can play in the open market. More than ever, the rep has an educational role: he or she serves as a pipeline of information to prescribers and payers that helps them make the best decisions in the patient's interest. Promotion is still important, but the focus is on gaining awareness and demonstrating value rather than courting prescribers. Today's representative works to get in front of the right opinion leaders at local and regional levels. Reps work alongside medical science liaisons (MSLs), nurse educators, and health economics outcomes research (HEOR) specialists to ensure clinical decision-makers have the information they need. Payers know that they share with pharma a desire to provide solutions for patients, and recognize that there are legitimate roles for pharma reps in advancing patient care…but the terms of engagement have changed.
Bottom line: Performance pays off
Despite calls for cost containment in health care, the age of the pharmaceutical blockbuster isn't over. Don't expect a warm welcome for your asset if it demonstrates me-too efficacy and safety or competes in a big category where close substitutes prevail. If, however, your novel therapy addresses a major unmet need and can demonstrate it convincingly, prescribers, payers, and patients eagerly await it and will pay accordingly.
Dominic Marasco, RPh, is Executive Vice President for Global Business Development and Commercial Solutions at Syneos Health. He also is Adjunct Associate Professor of Pharmaceutical and Health Economics at the University of Southern California and a member of the Health Policy and Management Executive Council at Harvard University's T.H. Chan School of Public Health.